Fresh Corneal Lenticule Implantation and Autologous Serum - New Approach in Treatment of Advanced Keratoconus Disease - Case Report
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Treatment of advanced keratoconus disease
研究概览
简要总结
The aim of our study is to investigate the feasibility and the effect of fresh lenticule implantation as allogenic graft that will be taken from myopic patients to implant in patients with keratoconus disease using VisuMax Femtosescond laser- Smile module surgery with primary objective to increase central corneal thickness and secondary to improve visual acuity and reduces K-values and to show the autologous serum drop improve the recovery of patients with mild dry eye in keratoconus disease.
详细描述
A 19-year-old female patient with keratoconus and chronic hydrops cornea referred to the cornea department of our clinic with thin cornea and hydrops in chronic stage and minimal dry eye symptoms. Minimum corneal pachymetry in the right eye was 378 µm as measured by optical coherence tomography(AS-OCT-Zeiss). Atlas corneal topography showed steep K-values 82.60 ax.37 and flat K 75.15 D ax 127 with -7.45 corneal astigmatism. Her best corrected visual acuity was 0.0.5 in right eye and 1.0 in the left eye. Slit lamp examination showed intense punctate epitheliopathy (Figure 1), tear film break-up time (TBUT) was measured as 7-8 sec and Schirmer test was 10 mm in right eye, and the other eye examinations were determined normally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 20 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be at least 18 years of age, male or female, of any race
- •Willingness and ability to follow all instructions and comply with schedule for follow-up visits
- •For females: Must not be pregnant
排除标准
- •Contraindications, sensitivity or known allergy to the use of the test article(s) or their components
- •If female, pregnant
研究组 & 干预措施
LENTICULE IMPLANTATION
The present study may suggest that this procedure safely, reliably, and effectively increases corneal thickness and improves visual acuity with no adverse effects. It may even provide new avenues in the treatment of corneal ectasia. Stem cells and live keratocytes are well organized based on cornea transparency and in anterior segment OCT.
干预措施: Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery (Other)
结局指标
主要结局
Treatment of advanced keratoconus disease
时间窗: 12 months
Change of corneal central thickness using fresh lenticule with stromal stem cells, live keratocites and autologous serum
次要结局
未报告次要终点
研究者
Dr. Faruk Semiz
Head of Ophthalmology Department
Eye Hospital Pristina Kosovo